Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003240

Protocol/serial number

LU3001

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lung (non-small cell) cancer

Intervention

1. Schedule A: Combination chemotherapy, four 3 weekly cycles of mitomycin, ifosfamide and cisplatin (MIC). Followed by radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour.

2. Schedule B: Radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour.

Intervention type

Drug

Phase

Not Specified

Drug names

Mitomycin, ifosfamide and cisplatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

01/01/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 75 years or under
2. Histologically or cytologically proven non-small cell lung cancer, ie adeno- squamous or large cell carcinoma
3. Clinically or radiologically evaluable disease 4. Inoperable, but clinically limited stage disease
5. WHO performance status of 0-2
6. No previous chemotherapy or radiotherapy
7. No metastatic disease, except ipsilateral stem cell factor (SCF) lymphadenopathy
8. Normal renal function
9. No other previous or concurrent malignancy, except cone biopsied carcinoma in-situ of the cervix and adequately treated basal cell carcinoma of the skin
10. No pleural effusion or symptomatic superior vena cava obstruction
11. No pre-existing severe impairment of lung function likely to prejudice the safe administration of the proposed radiotherapy
12. No indication that protocol treatment would exacerbate a serious pre-existing medical condition

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1990

Recruitment end date

01/01/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1995 interim analysis in http://www.ncbi.nlm.nih.gov/pubmed/7551939
1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10506617

Publication citations

  1. Interim analysis

    Cullen MH, Trials with mitomycin, ifosfamide and cisplatin in non-small cell lung cancer., Lung Cancer, 1995, 12 Suppl 1, S95-106.

  2. Results

    Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL, Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life., J. Clin. Oncol., 1999, 17, 10, 3188-3194.

Additional files

Editorial Notes